Format

Send to

Choose Destination
Drug Des Devel Ther. 2015 Jun 2;9:2847-54. doi: 10.2147/DDDT.S82098. eCollection 2015.

Efficacy of fimasartan/hydrochlorothiazide combination in hypertensive patients inadequately controlled by fimasartan monotherapy.

Author information

1
Cardiovascular Center, Dongguk University Ilsan Hospital, Goyang, Republic of Korea.
2
Catholic University of Korea, Seoul St Mary's Hospital, Seoul, Republic of Korea.
3
Cardiovascular Department of Internal Medicine, Kyung Hee University Medical Center, Seoul, Republic of Korea.
4
Division of Cardiology, Guro Hospital, Korea University College of Medicine, Seoul, Republic of Korea.
5
Division of Cardiology, Samsung Medical Center, Seoul, Republic of Korea.
6
Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.
7
Division of Cardiology, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, Republic of Korea.
8
Division of Cardiology, Asan Medical Center, Seoul, Republic of Korea.
9
Division of Cardiology, Ajou University Hospital, Suwon, Republic of Korea.
10
Division of Cardiology, Wonju Severance Christian Hospital, Wonju, Republic of Korea.
11
Division of Cardiology, GangNam Severance Hospital, Seoul, Republic of Korea.
12
Division of Cardiology, Severance Hospital, Seoul, Republic of Korea.
13
Division of Cardiology, Inje University Ilsan Hospital, Goyang, Republic of Korea.
14
Department of Cardiology, Chonnam National University Hospital, Gwangju, Republic of Korea.
15
Chonbuk National University Hospital, Jeonju, Republic of Korea.
16
Department of Cardiology, Cheil General Hospital, Dankook University College of Medicine, Seoul, Republic of Korea.
17
Department of Cardiology, Hanyang University Guri Hospital, Guri, Republic of Korea.
18
Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.

Abstract

BACKGROUND:

The study reported here compared the blood pressure (BP)-lowering efficacy of fimasartan alone with that of fimasartan/hydrochlorothiazide (HCTZ) combination in patients whose BP goal was not achieved after 4 weeks of treatment with once-daily fimasartan 60 mg.

METHODS:

Patients with sitting diastolic blood pressure (siDBP) ≥90 mmHg with 4 weeks of once-daily fimasartan 60 mg were randomly assigned to receive either once-daily fimasartan 60 mg/HCTZ 12.5 mg or fimasartan 60 mg for 4 weeks. After 4 weeks, the dose was increased from fimasartan 60 mg/HCTZ 12.5 mg to fimasartan 120 mg/HCTZ 12.5 mg or from fimasartan 60 mg to fimasartan 120 mg if siDBP was ≥90 mmHg.

RESULTS:

Of the 263 randomized patients, 256 patients who had available efficacy data were analyzed. The fimasartan/HCTZ treatment group showed a greater reduction of siDBP compared to the fimasartan treatment group at Week 4 (6.88±8.10 mmHg vs 3.38±7.33, P=0.0008), and the effect persisted at Week 8 (8.67±9.39 mmHg vs 5.02±8.27 mmHg, P=0.0023). Reduction of sitting systolic BP in the fimasartan/HCTZ treatment group was also greater than that in the fimasartan treatment group (at Week 4, 10.50±13.76 mmHg vs 5.75±12.18 mmHg, P=0.0069 and, at Week 8, 13.45±15.15 mmHg vs 6.84±13.57 mmHg, P=0.0007). The proportion of patients who achieved a reduction of siDBP ≥10 mmHg from baseline and/or a mean siDBP <90 mmHg after 4 weeks of treatment was higher in the fimasartan/HCTZ treatment group than in the fimasartan treatment group (53.6% vs 39.8%, P=0.0359). The overall incidence of adverse drug reaction was 11.79% with no significant difference between the treatment groups.

CONCLUSION:

The combination treatment of fimasartan and HCTZ achieved better BP control than fimasartan monotherapy, and had comparable safety and tolerance to fimasartan monotherapy.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01258673.

KEYWORDS:

angiotensin II type 1 receptor; angiotensin-converting enzyme inhibitor; angiotensin-receptor blocker; antihypertensive; blood pressure; renin–angiotensin–aldosterone system inhibitor

PMID:
26082615
PMCID:
PMC4459623
DOI:
10.2147/DDDT.S82098
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for Dove Medical Press Icon for PubMed Central
Loading ...
Support Center